510(k) · Cleared

Cleared

Flexposure Retractor

K983144510(k) TraditionalCleared Feb 24, 1999169-day reviewClass II21 CFR 888.1100

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cleared on Feb 24, 1999 as substantially equivalent to K955471 (Sofamor Danek USA,Inc., 1995) and 2 other predicates after a 169-day review. Its family tree reaches back 1 generation to 1995. 15 later devices descend from it.

Decided: Feb 24, 1999
Review: 169 days
Class: Class II
Product code: HRX
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K950130 (1995). 3 ancestors in all. 15 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK950130 Micro-Endo (TM) InstrumentsSofamor Danek USA,Inc. · 1995
This deviceK983144 Flexposure RetractorEndius, Inc. · 1999
Descendant · cites it directly · 14 of its ownK062038 X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp. · 2006
Descendant · 2 generations on · 13 of its ownK093062 Vertos Medical Mild Device KitX-Sten Corp. · 2010
Descendant · 3 generations on · 7 of its ownK180876 DTRAX Spinal SystemProvidence Medical Technology, Inc. · 2018
Descendant · 4 generations on · 6 of its ownK190201 CORUS Spinal SystemProvidence Medical Technology, Inc. · 2019
Descendant · 3 generations on · 5 of its ownK212636 CORUS Spinal System-XProvidence Medical Technology, Inc. · 2021

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2006high 4 (2026) · low 0 (2007)2026

Most influential descendants

Showing 5 of 15 · See all

K062038X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp. · 2006 · cites it directly14descendants
K093062Vertos Medical Mild Device KitX-Sten Corp. · 2010 · 2 generations on13descendants
K180876DTRAX Spinal SystemProvidence Medical Technology, Inc. · 2018 · 3 generations on7descendants
K190201CORUS Spinal SystemProvidence Medical Technology, Inc. · 2019 · 4 generations on6descendants
K212636CORUS Spinal System-XProvidence Medical Technology, Inc. · 2021 · 3 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K950130	Micro-Endo (TM) Instruments	Sofamor Danek USA,Inc.	1995	—
0 (this device)	K983144	Flexposure Retractor	Endius, Inc.	1999	—
+1	K062038	X-Sten Mild Tool Kit, Model MTK-0001	X-Sten Corp.	2006	—
+2	K093062	Vertos Medical Mild Device Kit	X-Sten Corp.	2010	—
+3	K180876	DTRAX Spinal System	Providence Medical Technology, Inc.	2018	—
+4	K190201	CORUS Spinal System	Providence Medical Technology, Inc.	2019	—
+3	K212636	CORUS Spinal System-X	Providence Medical Technology, Inc.	2021	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2010	1	0
2012	1	0
2018	1	0
2019	1	0
2021	1	0
2024	2	0
2025	3	0
2026	4	0

FIG. 1 — Lineage of K983144, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HRX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new HRX device

#1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K955471	Incl Endoscope Summary page 1 …al Name: Retractor Classification Name: Manual Surgical Instrument PREDICATE DEVICES (783144 Retractor included in the Sofamor Danek MED Microendoscopic Discectomy, K955471, K950501 and K950130. DEVICE DESCRIPTION The Flexposure Retractor is a manual surgical instrument intended for use in posterior…	Sofamor Danek USA,Inc.	1995	—
*	K950501	Danek Rigid Arthroscope Summary page 1 …Retractor Classification Name: Manual Surgical Instrument PREDICATE DEVICES (783144 Retractor included in the Sofamor Danek MED Microendoscopic Discectomy, K955471, K950501 and K950130. DEVICE DESCRIPTION The Flexposure Retractor is a manual surgical instrument intended for use in posterior endoscop…	Sofamor Danek USA,Inc.	1995	—
*	K950130	Micro-Endo (TM) Instruments Summary page 1 …lassification Name: Manual Surgical Instrument PREDICATE DEVICES (783144 Retractor included in the Sofamor Danek MED Microendoscopic Discectomy, K955471, K950501 and K950130. DEVICE DESCRIPTION The Flexposure Retractor is a manual surgical instrument intended for use in posterior endoscopic microdisc…	Sofamor Danek USA,Inc.	1995	—

Also cleared against K955471: 2 other devices →

What descends from it? (15)

See all 15

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K062038	X-Sten Mild Tool Kit, Model MTK-0001	X-Sten Corp.	2006	14

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 3 ancestors has a recall.
Of its descendants, K062038 (X-Sten Corp., 2006) has gone furthest, with 14 descendants of its own.
2 other devices also cite its predicate K955471.

How does its category compare?

All HRX devices

HRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRX

9in 2025

2007high 12 (2013) · low 3 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRX

107in 2025

2007high 249 (2023) · low 45 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRX

1in 2024

2007high 23 (2009) · low 0 (2012)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRX

2,076in 2025

2007high 2,427 (2024) · low 421 (2007)2025

MAUDE reports naming product code HRX, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	7	89	3	421
2008	9	115	13	441
2009	11	139	23	558
2010	9	114	12	612
2011	3	84	6	631
2012	11	102	0	778
2013	12	90	4	678
2014	9	140	0	802
2015	4	132	7	763
2016	8	89	0	469
2017	4	97	0	934
2018	12	101	1	1,581
2019	12	45	0	1,676
2020	7	141	0	1,706
2021	7	57	3	1,908
2022	3	89	0	1,406
2023	4	249	0	1,852
2024	6	110	1	2,427
2025	9	107	0	2,076
2026	7	217	0	—

What is it indicated for?

The Flexposure Retractor is a manual surgical instrument intended to provide endoscopic access to the posterior lumbar spine by retracting tissues during endoscopic discectomy procedures.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K983144 · printed Nov 5, 2026

Cite this page

510(k) Report. “K983144: Flexposure Retractor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983144

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026